Quality Engineer - Medical Devices - Dover, NH

The Quality Engineer, Medical Device Manufacturing, will support and enforce the Quality Management System, ensuring compliance with ISO 13485 and regulatory requirements in the production of disposable medical products. This role will provide hands-on leadership within a Value Stream Business Unit, driving process improvements, root cause analysis, and customer quality initiatives at our Dover, NH facility.

Client Details

My client is a specialized contract manufacturer focused exclusively on the medical device industry, providing design, development, and manufacturing solutions for complex electromechanical and single-use devices. With multiple locations in North America, they partner with OEMs to deliver high-quality, regulatory-compliant products across the entire product lifecycle. Their expertise spans concept ideation, lean-focused manufacturing, assembly, and aftermarket services, ensuring continuous improvement and operational excellence. Their collaborative and quality-driven culture empowers employees to develop innovative solutions that enhance patient outcomes.

Description

The Quality Engineer, Medical Device Manufacturing will:

• Ensure compliance with ISO 13485, FDA regulations, and other applicable standards
• Serve as the primary quality interface for assigned customers and suppliers
• Investigate and resolve customer complaints, non-conformances, and supplier quality issues
• Lead root cause analysis and corrective action initiatives for production and components
• Develop and execute validation plans for new and transferred products/processes
• Maintain and improve quality plans, risk assessments, and technical documentation
• Participate in internal and supplier audits, ensuring adherence to regulatory requirements
• Support continuous improvement initiatives through process optimization and defect reduction
• Manage customer deliverables and documentation, ensuring timely approvals
• Lead CAPA investigations and drive preventive action strategies
• Provide quality support for manufacturing operations, addressing deviations and test procedures
• Present quality metrics and trends during customer business reviews
• Onsite at our Dover, NH facility

Profile

• Strong understanding of ISO 13485, FDA 21 CFR Part 820, and risk management per ISO 14971
• Experience with root cause analysis methodologies (e.g., Fishbone Diagrams, Fault Tree Analysis)
• Proficiency in statistical analysis and data interpretation using Minitab or similar tools
• Hands-on experience managing non-conformances, CAPAs, and quality documentation
• Background in risk analysis, validation protocols, and process improvements
• Excellent written and verbal communication skills for customer and supplier interactions
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio)
• Strong presentation and training skills for internal and external stakeholders
• Ability to lead quality initiatives within a cross-functional production environment
• Experience supporting audits from regulatory bodies, customers, and suppliers
• Bachelor's degree in engineering, biology, or related science
• 2-5 years of quality engineering experience in medical device manufacturing
• Local to Dover, NH

Job Offer

• Comprehensive healthcare options, including medical, dental, and vision
• Company-sponsored short-term and long-term disability insurance
• Life insurance coverage provided by the company
• 401(k) retirement plan with company contribution
• Paid time off, including holidays and a dedicated birthday leave
• Employee referral bonus program
• Career growth opportunities within a quality-driven and innovative organization

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.